- Warszawa, mazowieckie
- Pełny etat
- 13 dni temu
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person. We are now offering opportunity in our group within Late-stage development CVRM (Cardiovascular, Renal and Metabolism). The position is based at our site in Warsaw, Poland.
In Late-stage development CVRM you will be given the opportunity to work in a truly international working environment, with opportunities to meet and discuss with key external specialists, other medical colleagues and experts in basic science, as well as commercial and regulatory functions.
Our therapy area aligned groups of physicians and scientists provide clinical guidance and scientific leadership for clinical development programs within AstraZeneca's global organization.
Global Clinical Development Medical Director is a Research Physician providing medical expertise in cross functional global teams to develop medicines through design, conduct and reporting of clinical studies. The role holder also interacts with external medical experts and regulatory agencies as well as contributes to publications and presents at congresses.
As a Clinical Research Physician, you will conduct clinical trials, including the design, monitoring, data interpretation and reporting. An important task is to ensure that all clinical studies operate to the highest ethical and safety standards and in compliance with Good Clinical Practice (GCP) and regulatory requirements. As a Clinical Research Physician, you will support the clinical project team and assist the Global Clinical Head with the design & interpretation process, establishing clear design objectives for clinical programs and studies. You will provide medical input into the content of core labelling texts and medical support for commercial activities, as well as the scientific component of the pricing and value strategy.
Medical expert accountabilities:
- Provides strategic medical and scientific knowledge and supports in the design, initiation, execution, completion and interpretation of a clinical study
- Is accountable for study designs and study design concept delivery
- Is accountable to deliver medical information, answers, and clarifications to Regulators, Ethic Committees, Marketing Companies, Investigators/Sites
- Is accountable to the Global Clinical Head (GCH) or delegate for the medical aspects and designs of studies
- Is responsible for driving decisions within Study Team (ST) remits together with other ST members and for solving medical issues in the Study Team
- Is accountable for the medical and ethical components of studies including patient safety on a study level in compliance with GCP
- Is accountable for delivery of all relevant study documents (e.g Protocol, Statistical Analysis Plan, Amendments, Informed Consent Form, Case Report Forms, Safety and Risk-Based Monitoring Plans)
- Is accountable for safety surveillance including the process for Adverse Events (AE)/ Serious AE reporting, querying investigator on missing/unclear data, review of blinded safety data and escalation to GCH/Global Safety Physician when needed.
- Is medically accountable for international investigator meetings, and support to Marketing Companies (MC) in national activities
- Approves (with the GCH) the Clinical Study Report; including preparation and production thereof (Introduction, Results, Discussion).
- Is accountable for Study Team induction and education of new members, as well as others involved in the study
- Collaborates seamlessly and efficiently with global colleagues at other R&D sites
- May be accountable to GCH(or delegate) and leadership for identifying risks and proposing mitigation strategies to also deliver successful Phase IIb, III, IV or Life Cycle Management studies
- Stays updated on scientific relevant literature and is able to message key impactful points, as applicable
- Delivers analyses of clinical data in a balanced, statistically sound fashion, to drive interpretations and further idea generation
- Serves as a source of medical expertise for the Product Team, in analyses and interpretation of medical data
- Maintains a high degree of understanding and awareness on new and emerging medical development, globally
- Works with international colleagues and with external Alliance partners on development initiatives and regulatory issues
- Applies strategic intent of AstraZeneca when working with Alliance partners, Regulatory Authorities, payers, opinion leaders, prescribers and consumers of AstraZeneca products
- Able to provide mentorship for investigator-initiated trials in cooperation with regional marketing companies
- Graduate of a recognized school of medicine with an M.D. degree
- Proficient in oral and written English
- ≥3 years clinical research experience in relevant therapy area in study design, protocol development, monitoring and implementing clinical trials, interpreting and reporting trial results
- Good knowledge of biostatistics, global regulatory environment and pharmacovigilance
- Proven teamwork and collaboration skills
- Good presentation skills and effective communication
- Leadership skills with particular focus on collaborative working skills, trust and openness, irrespective of cultural setting
- AstraZeneca values and behaviours
- Agile responsiveness to scientific data
- Credibility in scientific and commercial environments
- PhD (or other complementary degree) in scientific subject area
- Education in Pharmaceutical Medicine
- Good general medical knowledge in endocrinology, cardiology or nephrology
- An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence drug development.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.
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